LUPRON DEPOT SUMMARY

LUPRON DEPOT3 Month 11.25 mg is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRON DEPOT with norethindrone acetate 5 mg daily is also indicated for initial management of endometriosis and for management of recurrence of symptoms. (Refer also to norethindrone acetate prescribing information for WARNINGS, PRECAUTIONS, CONTRAINDICATIONS and ADVERSE REACTIONS associated with norethindrone acetate). Duration of initial treatment or retreatment should be limited to 6 months.

Uterine Leiomyomata (Fibroids)

LUPRON DEPOT3 Month 11.25 mg concomitantly with iron therapy is indicated for the preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata. The clinician may wish to consider a one-month trial period on iron alone inasmuch as some of the patients will respond to iron alone. (See
Table 1, CLINICAL STUDIES
section.) LUPRON may be added if the response to iron alone is considered inadequate. Recommended therapy is a single injection of LUPRON DEPOT3 Month 11.25 mg. This dosage form is indicated only for women for whom three months of hormonal suppression is deemed necessary.

Experience with LUPRON DEPOT3 Month 11.25 mg in females has been limited to women 18 years of age and older treated for no more than 6 months.

- One way to treat certain cancers of the blood and immune system is to give a patient

stem cells from the bone marrow of a donor whose genes are very similar but not
identical to the patient s. One problem with these transplants is that the new immune
cells may not work as well in the recipient as they did in the donor. The result may be
that the immune system will not work as well. This can increase the risk of severe
infections and other complications.

- Researchers are studying the use of drugs that lower hormone levels and may allow the

immune system to recover in a way that improves white blood cell function. In this
study they will be looking at the drug lupron, a drug that lowers estrogen or
testosterone levels, to see if it might improve the function of the newly transplanted
cells.
Objectives:

transplantation from a donor with similarities in their immune cells (matched to each
other).

- To evaluate the effectiveness of a nuclear medicine test with a radiotracer drug FLT in

imaging studies. FLT will be used to image the immune system function in patients who
have received bone marrow from the donor.
Eligibility:

- People between 15 (or as young as 9 in those who have gone through puberty) and 40

years of age. These patients must have acute myelogenous leukemia, acute lymphocytic
leukemia, or high-risk myelodysplastic syndrome. They must also be eligible for a bone
marrow transplant.

- Genetically similar donors for the patients who are eligible for a transplant.

Design:

- People taking part in the study will be screened with a physical examination, medical

history, blood and urine tests, and imaging studies. Patients who are not in remission
or who require a bone marrow donor search may receive chemotherapy first.

- Donors will provide bone marrow for transplant according to standard bone marrow

transplant (BMT) procedures.

- All women and half of the men will receive regular lupron doses 2 weeks before BMT to

suppress hormone function.

- All recipients will receive 4 days of radiation followed by 2-4 days of chemotherapy

before the bone marrow transplant (depending on age). Recipients will also receive
other drugs to prevent transplant rejection and other complications of transplantation.

- Recipients will be monitored in the hospital for 4 weeks after transplant with blood

tests and other studies.

- Some recipients will have an imaging study with FLT during the protocol. These imaging

studies will take place before the transplant, on days 5 and 28 after transplant, and
at a later time to be determined by the study researchers.

- Following discharge, participants will be monitored closely for up to 6 months, with

regular but less frequent followup visits for at least 5 years. Study-related
medications, including vaccinations for the new immune system, will be provided by the
National Institutes of Health during the hospital stay and after discharge.

Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg) [Active, not recruiting]
(A) Major 1) to compare the effectiveness of norethindrone acetate (NA) with GnRH agonist
(Lupron-Depot-3) in relieving symptoms of endometriosis, 2) to compare bone density in the
two treated groups in order to demonstrate that NA does not affect bone density; (B) Minor:
1) To compare the lipid profiles of patients in the two groups to confirm the hypothesis
that the effects of NA and GnRH agonists on lipid profiles are similar, 2) To determine
whether quality of life, assessed by questionnaire, is better in patients assigned to NA
than in patients assigned to GnRH, 3) To determine whether NA has fewer adverse effects than
GnRH agonist.

A Study of Leuprolide to Treat Prostate Cancer [Completed]
To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month
depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A
formulation will be deemed successful if the percentage of subjects with suppression of
testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of
the 2-sided 90% confidence interval), a protocol-specified criterion.